Ivermectin
Generic: IVERMECTIN
Basic Information
Manufacturer
Bryant Ranch Prepack
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
81193a2d-dc0a-4ce5-a5c1-6dfd3195c4bc
Indications & Usage
1 INDICATIONS AND USAGE Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea.
Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea.
( 1 )
Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS In controlled clinical trials with ivermectin cream the most common adverse reactions (incidence less than or equal to 1 %) included skin burning sensation and skin irritation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc.
at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical trials, 2,047 subjects with inflammatory lesions of rosacea received ivermectin cream once daily.
A total of 1,555 subjects were treated once daily for more than 12 weeks, and 519 for approximately one year.
Adverse reactions, reported in less than or equal to 1% of subjects treated with ivermectin cream for at least 3 months in vehicle-controlled clinical trials, included skin burning sensation and skin irritation.
6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Local adverse reactions: contact dermatitis and allergic dermatitis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc.
at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical trials, 2,047 subjects with inflammatory lesions of rosacea received ivermectin cream once daily.
A total of 1,555 subjects were treated once daily for more than 12 weeks, and 519 for approximately one year.
Adverse reactions, reported in less than or equal to 1% of subjects treated with ivermectin cream for at least 3 months in vehicle-controlled clinical trials, included skin burning sensation and skin irritation.
6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Local adverse reactions: contact dermatitis and allergic dermatitis.